UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) announced that it has received marketing approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its Blenrep (belantamab mafodotin). The BCMA-targeted antibody-drug conjugate (ADC) can now be used to treat adult patients with relapsed or refractory multiple myeloma (MM) in Japan, in combination with other drugs.
Clinical Trial Support
The approval from the MHLW is supported by positive results from the Phase III DREAMM-7 and DREAMM-8 studies. These studies assessed Blenrep in combination with bortezomib plus dexamethasone (BVd) and in combination with pomalidomide plus dexamethasone (BPd), respectively, in MM patients who have received at least one prior therapy.
Blenrep Technology and Previous Approvals
Blenrep is an ADC comprising a humanized BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc., while the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group. Blenrep was approved last month in the UK for use in combination with other drugs in MM patients previously treated with at least one therapy.-Fineline Info & Tech
